Auralay Pit & Fissure Sealant
FDA 510(k) K071158 · Denali Corporation
510(k) numberK071158
Submission
- Device name
- Auralay Pit & Fissure Sealant
- Applicant
- Denali Corporation
Hanover, MA, US - Received
- April 25, 2007
- Decision date
- June 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | Parkell, Inc. | 08/08/2025SE |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioEBC · Traditional | Ultradent Product, Inc. | 08/18/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 07/25/2023SE |
| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | Apex Dental Materials, Inc. | 11/08/2019SE |
| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
| K162598 | HAPI SealEBC · Traditional | Bisco, Inc. | 05/23/2017SE |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
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| K152322 | Resolve 2.0PME · Traditional | 12/16/2015SE |
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| K132393 | Cercom II CementEMA · Traditional | 03/14/2014SE |
| K073101 | Auraveneer CementEMA · Traditional | 01/17/2008SE |
| K070702 | Fusion Resin Cement and Core KitEBF · Traditional | 05/10/2007SE |
| K070693 | Auravue Pit & Fissure SealantEBF · Traditional | 05/09/2007SE |
Questions and answers
When was Auralay Pit & Fissure Sealant cleared by the FDA?
Auralay Pit & Fissure Sealant (K071158) received a 510(k) decision of Substantially Equivalent on June 5, 2007, 41 days after the submission was received.
What is the product code of K071158?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.